NPPA fixes retail price of 19 formulations including Metformin, Dapagliflozin, Details
New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India, has fixed the retail price of 19 formulations, including non steroidal anti inflammatory drug combinations, antidiabetic drug combinations, proton pump inhibitors, and others.These include Dallas Drugs/Alkem's Rabeprazole Sodium plus...
New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India, has fixed the retail price of 19 formulations, including non steroidal anti inflammatory drug combinations, antidiabetic drug combinations, proton pump inhibitors, and others.
These include Dallas Drugs/Alkem's Rabeprazole Sodium plus Ondansetron Hydrochloride, Softdeal Pharmaceutical's anti inflammatory drug combination Diclofenac Sodium plus Paracetamol Tablet, Unison Pharmaceutical's Calcium Carbonate plus Vitamin D3 Tablet, Hetero Healthcare's Diclofenac Diethylamine, Methyl Salicylate, Capsaicin, Menthol & Linseed Oil Gel, etc.
The list further includes the popular anti-diabetic drug combination Dapagliflozin plus Metformin Hydrochloride, manufactured by Synokem Pharmaceuticals and marketed by Lupin, Primus Remedies and Indoco Remedies.
This price fixation is followed by the decisions made by the National Pharmaceutical Pricing Authority at its 223rd meeting, where the authority discussed the cases of retail price fixation of new drugs falling under the purview of Para 2 (u) of the DPCO, 2013 and approved the retail prices of said drugs under Para 5 and 15 of the DPCO 2013.
This comes in exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S. O. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (NPPA), has fixed, the price as specified in column (6) of the table herein below as the retail price, exclusive of Goods and Services Tax, if any, in relation to the formulation specified in the corresponding entry in column (2) of the said Table with the strength, unit and name of manufacturer & marketing company, as specified in the corresponding entries in columns (3), (4) and (5) thereof;
Sl. No. | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
(1) | (2) | (3) | (4) | (5) | (6) |
1. | Diclofenac Sodium + Paracetamol Tablet IP | Each uncoated tablet contains: Diclofenac Sodium IP 50mg, Paracetamol IP 325mg | 1 Tablet | M/s Softdeal Pharmaceutical Pvt. Ltd. | 4.14 |
2. | Calcium Carbonate + Vitamin D3 Tablet | Each Film coated tablet contains: Calcium Carbonate IP 1250mg eq. to Elemental Calcium 500mg, Vitamin D3 IP 1000IU | 1 Tablet | M/s Unison Pharmaceuticals Pvt. Ltd. | 5.36 |
3. | Zinc Sulphate | Each pack of 200ml contains: | 30.00 | ||
Monohydrate + | Zinc Sulphate Monohydrate IP 0.0110 g | ||||
Sodium Citrate + Potassium Chloride + Dextrose | Sodium Citrate IP 0.5800 g Potassium Chloride IP 0.3000 g Sodium Chloride IP 0.5200 g Dextrose Anhydrous IP 2.7000 g | Each 200ml Pack | M/s Halewood Laboratories Pvt. Limited / M/s FDC Limited | ||
Anhydrous Oral | |||||
Solution | |||||
4. | Rabeprazole Sodium + Ondansetron Hydrochloride Tablet | Each Enteric coated tablet contains: Rabeprazole Sodium IP 20mg Ondansetron Hydrochloride eq. to Ondansetron IP 4mg | 1 Tablet | M/s Dallas Drugs Pvt. Ltd. / M/s Alkem Laboratories Limited | 10.00 |
5. | Paracetamol, | Each 5ml contains: | 0.64 | ||
Phenylepherine | Paracetamol IP 125mg | ||||
Hydrochloride, | Phenylepherine Hydrochloride IP 5mg | M/s Shiv Industries / | |||
Chlorpheniramine | Chlorpheniramine Maleate IP 0.5mg | 1 ML | M/s Profic Organic | ||
Maleate, Sodium | Sodium Citrate IP 60mg | Limited | |||
Citrate and | Menthole IP 1mg | ||||
Menthol Syrup | |||||
6. | Dapagliflozin + Metformin Hydrochloride (As Extended release form) Tablet | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 5mg, Metformin Hydrochloride IP 500mg (As Extended release form) | 1 Tablet | M/s Synokem Pharmaceuticals Ltd. / M/s Lupin Limited | 6.25 |
7. | Dapagliflozin + Metformin Hydrochloride (As Extended release form) Tablet | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 5mg, Metformin Hydrochloride IP 1000mg (As | 1 Tablet | M/s Synokem Pharmaceuticals Ltd. / M/s Lupin Limited | 7.54 |
Sl. No. | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
(1) | (2) | (3) | (4) | (5) | (6) |
Extended release form) | |||||
8. | Dapagliflozin + Metformin Hydrochloride (As Extended release form) Tablet | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 500mg (As Extended release form) | 1 Tablet | M/s Synokem Pharmaceuticals Ltd. / M/s Lupin Limited | 9.65 |
9. | Dapagliflozin + Metformin Hydrochloride (As Extended release form) Tablet | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 1000mg (As Extended release form) | 1 Tablet | M/s Synokem Pharmaceuticals Ltd. / M/s Lupin Limited | 11.17 |
10. | Methylcobalamin,Alpha Lipoic Acid,Vitamin D3,Pyridoxine,Hydrochloride & Folic Acid Tablet | Each film coated tablet contains: | 10.97 | ||
Methylcobalamin IP 1500mcg, | M/s Akums Drugs & | ||||
Alpha Lipoic Acid USP 100mg, | 1 | Pharmaceuticals | |||
Vitamin D3 IP 1000 IU, | Tablet | Limited / M/s Abbott | |||
Pyridoxine Hydrochloride IP 3mg, Folic Acid IP 1.5mg | Healthcare Pvt. Ltd. | ||||
11. | Methylcobalamin,Alpha Lipoic Acid,Vitamin D3,Pyridoxine Hydrochloride & Folic Acid Tablet | Each film coated tablet contains: | M/s Unison Pharmaceuticals Pvt. Ltd. | 10.97 | |
Methylcobalamin IP 1500mcg, | |||||
Alpha Lipoic Acid USP 100mg, | 1 | ||||
Vitamin D3 IP 1000 IU, | Tablet | ||||
Pyridoxine Hydrochloride IP 3mg | |||||
Folic Acid IP 1.5mg | |||||
12. | Diclofenac Diethylamine, Methyl Salicylate, Capsaicin,Menthol & Linseed Oil Gel | Composition: Diclofenac Diethylamine IP 1.16% w/w eq. to Diclofenac Sodium 1.0% w/w, Methyl Salicylate IP 10%w/w, Capsaicin USP 0.025% w/w, Menthol IP 5.0% w/w Linseed Oil BP 3.0% w/w | 1 GM | 2.70 | |
M/s Hetero Healthcare Ltd. | |||||
13. | Dapagliflozin + Metformin Hydrochloride (As Extended release form) Tablet | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 5mg, Metformin Hydrochloride IP 500mg (As Extended release form) | 1 Tablet | M/s Synokem Pharmaceuticals Ltd. / M/s Primus Remedies Pvt Ltd | 6.25 |
14. | Dapagliflozin + Metformin Hydrochloride (As Extended release form) Tablet | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 500mg (As Extended release form) | 1 Tablet | M/s Synokem Pharmaceuticals Ltd. / M/s Primus Remedies Pvt Ltd | 9.65 |
15. | Dapagliflozin + Metformin Hydrochloride (As Extended release form) Tablet | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 1000mg (As Extended release form) | 1 Tablet | M/s Synokem Pharmaceuticals Ltd. / M/s Primus Remedies Pvt Ltd | 11.17 |
16. | Dapagliflozin + Metformin Hydrochloride (As Extended release form) Tablet | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 500mg (As Extended release form) | 1 Tablet | M/s Synokem Pharmaceuticals Ltd. /M/s Indoco Remedies Limited | 9.65 |
Sl. No. | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
(1) | (2) | (3) | (4) | (5) | (6) |
17. | Dapagliflozin + Metformin Hydrochloride (As Extended release form) Tablet | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 1000mg (As Extended release form) | 1 Tablet | M/s Synokem Pharmaceuticals Ltd. /M/s Indoco Remedies Limited | 11.17 |
18. | Dapagliflozin + Metformin Hydrochloride (As Extended release form) Tablet | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 5mg, Metformin Hydrochloride IP 1000mg (As Extended release form) | 1 Tablet | M/s Synokem Pharmaceuticals Ltd. / M/s Primus Remedies Pvt Ltd | 7.54 |
19. | Calcium Carbonate +Vitamin D3 Methylcobalamin + Calcium L-5 Methyltetrahydrofolate & Pyridoxal –5- Phosphate Tablet | Each Film coated tablet contains: Calcium Carbonate IP 1250mg eq. to Elemental Calcium 500mg,Vitamin D3 IP 2000IU Methylcobalamin IP 1500mcg, Calcium L-5-Methyltetrahydrofolate USP1mg, Pyridoxal – 5- Phosphate 20mg | 1 Tablet | M/s Unison Pharmaceuticals Ltd. | 17.12 |
The notification further added;
(a) The manufacturer of above mentioned formulations i.e. "new drug" under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (6) of the table hereinabove.
(b) The manufacturer may add Goods and Services Tax only if they have paid actually or it is payable to the Government on the retail price mentioned in column (6) of the above said table.
(c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (6) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to the State Drug Controllers and dealers.
(d) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.
(e) The above mentioned retail price is applicable only to the individual manufacturer / marketer as mentioned above i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 2013 and subject to fulfilment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturer/marketing companies.
(f) In case the retail price of any of the aforesaid formulations is not complied with, as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.
(g) Consequent to the issue of ceiling price of such formulation as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded.
To view the official notice, click the link below:
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